EXACT Therapeutics receives regulatory approval to start recruitment of patients at Oslo University hospital
OSLO, 31 October 2023: EXACT THERAPEUTICS AS (“EXACT-Tx”, Euronext Growth: EXTX), a clinical stage precision medicine company utilising Acoustic Cluster Therapy (ACT®) across multiple therapeutic areas, today announces that the Norwegian Medicines Agency (NOMA) and the Ethics Committee have awarded all necessary approvals to start recruitment of patients into the dose expansion part of the ACTIVATE study in Norway. This follows the recently announced approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The approvals means that EXACT-Tx may initiate recruitment of patients at Oslo University Hospital for the dose expansion part of the ACTIVATE study. This part of the ACTIVATE study is designed to determine the dose level for further development and expand the safety and efficacy data of ACT in patients with metastatic colorectal cancer. 12 to 20 patients are planned to be enrolled into the dose expansion part of the ACTIVATE study.
Per Walday, CEO, comments: “We are very pleased being able to start recruiting patients at the Oslo University Hospital in Norway, in addition to the already included sites in the UK. A strong relationship with the clinical expertise in Norway is important to us and we look forward to start recruiting Norwegian patients into the dose expansion in ACTIVATE.”
For more information, please contact:
Per Walday
CEO EXACT Therapeutics
Email: per.walday@exact-tx.com
About EXACT-Tx:
EXACT-Tx is a clinical-stage Norwegian precision medicine company developing a technology platform for targeted therapeutic enhancement – Acoustic Cluster Therapy (ACT®). ACT follows a unique approach to ultrasound-mediated, targeted drug enhancement – with the potential to significantly amplify the clinical utility of a wide range of therapeutic agents across a multitude of indications including within oncology (chemotherapy, immunotherapy) and brain diseases. www.exact-tx.com
About ACT®
• ACT® is a proprietary formulation consisting of microbubbles and microdroplets that are activated through the application of ultrasound with the consequent increase in targeted delivery of a co-administered therapeutic agent.
• ACT® is supported by a strong and broad preclinical package demonstrating therapeutic enhancement in multiple oncology models (pancreatic, breast, colon, prostate) as well as blood-brain barrier penetration.
• Initial focus of the Company is oncology, however the ACT® platform has potential across therapeutic areas (CNS, immunotherapy) and product classes.
Forward looking statements: This announcement and any materials distributed in connection with this announcement may contain certain forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the Company's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of material factors could cause actual results and developments to differ materially from those expressed or implied by this forward-looking statement.